SPL Process Team - Generic Drugs Subgroup Meeting
September 8, 2008, 1pm EDST
Meeting Minutes
Agenda for SPL Generic Sub Team Meeting September 8, 2008
1. Meeting minutes – any comments?
2. Wiki – has anyone logged in?
3. Comments – due to the FDA tomorrow. Will submit via e-mail.
4. DIA Webinar tomorrow – 76 signups so far.
5. GPhA F2F – SPL R4 – October 28 in Washington, DC.
Virginia Hogan/Teva will attend representing Generic Sub Team.
6. DIA F2F – SPL R4 – October 29 & 30 in Philadelphia.
Jeffery Karp/RA-IT Associates will attend representing Generic Sub Team.
7. Waivers for SPL R4 – will be difficult to obtain.
8. Look at whole process for your company.
3. Comments – due to the FDA tomorrow. Will submit via e-mail.
Waiver
Comment about one waiver – from the federal register – 1 registration per company per year - one waiver annually
Lonnie responded about low number of waivers expected to be necessary
Costs
Comment about costs
Per label costs high
Process change cost significant
DUNS
DUNS cost significant – credit report plus duns; can’t get it without doing it this way if the company doesn’t know the DUNS number – Lonnie says will ask from D&B at the seminar
Questions about DUNS numbers
What’s the minimum info to give D&B so the registration number could be gotten without this major expense? Is that a way that would work to reduce the workload on both sides as well as the cost? Craig T to follow-up at Webinar on September 9
Question – find vendors DUNS number - finding vendors on our own is less expensive but requires time (extensive time – both calendar and effort)
Is the NDC OK rather than DUNS? FDA response: NDC lets FDA know what establishment is involved – that is acceptable (for right now)
FDA says – Information from Ryan Paul at D&B – about $4 per DUNS if you have account.
Is there an initial $5000 membership fee required? This will be checked
Layout
Order of comments – The comments will be put in a priority order.
4. DIA Webinar tomorrow – 76 signups so far
.
This is the September 8 Webinar. Several members are attending.
5. GPhA F2F – SPL R4 – October 28 in Washington, DC.
Virginia Hogan/Teva will attend representing Generic Sub Team.
6.
DIA F2F – SPL R4 – October 29 & 30 in Philadelphia.
Jeffery Karp/RA-IT Associates will attend representing Generic Sub Team.
7. Waivers for SPL R4 – will be difficult to obtain.
Discussion above
8. Look at whole process for your company.
Different departments being merged to make this process into one group.
Need feedback from other companies to see how this is affecting you.
9. Other/New
Meeting participation is strongly encouraged.
One method suggested is contacting group members regarding issues for future meeting agenda.
Another is a survey/questionnaire to establish the needs of the group.
10. New developments after SPL Generic Sub Team Meeting:
Slides from webinar will be sent out with Meeting Minutes.
It was confirmed by D&B that if just a DUNs number is requested the cost should be $3.55. No membership fee is required.
Our comments were sent to the FDA via GPhA under their letterhead.
10. Meeting attendee list below.
If you attended and are not on the list, please let me know.
11. The next Generic Sub Team meeting is on Monday, September 22
Please send me any agenda items you wish to be discussed.
Call in information:
Toll Free Dial In Number: (866) 618-6746
Int'l Access/Caller Paid Dial In Number: (201) 527-2133
ACCESS CODE: 8957842 Generic Sub Team – Attendees 9/8/08
SPL Process Team - Generic Drugs Subgroup Meeting
September 8, 2008, 1pm EDST
Meeting Minutes
Agenda for SPL Generic Sub Team Meeting
September 8, 2008
1. Meeting minutes – any comments?
2. Wiki – has anyone logged in?
3. Comments – due to the FDA tomorrow. Will submit via e-mail.
4. DIA Webinar tomorrow – 76 signups so far.
5. GPhA F2F – SPL R4 – October 28 in Washington, DC.
Virginia Hogan/Teva will attend representing Generic Sub Team.
6. DIA F2F – SPL R4 – October 29 & 30 in Philadelphia.
Jeffery Karp/RA-IT Associates will attend representing Generic Sub Team.
7. Waivers for SPL R4 – will be difficult to obtain.
8. Look at whole process for your company.
1. Meeting minutes – any comments?
Minutes accepted without comment
2. Wiki – has anyone logged in?
Several people have.
Some notes on what is available on the wiki.
Submissions flow - "Submissions Flow Chart for R3 and R4"
Docket comments - "Important Documents"
DUNS Number - "DUNS Number FAQ"
There is a possibility of tying the Wiki to the HL7-SPL information.
3. Comments – due to the FDA tomorrow. Will submit via e-mail.
Waiver
Comment about one waiver – from the federal register – 1 registration per company per year - one waiver annually
Lonnie responded about low number of waivers expected to be necessary
Costs
Comment about costs
Per label costs high
Process change cost significant
DUNS
DUNS cost significant – credit report plus duns; can’t get it without doing it this way if the company doesn’t know the DUNS number – Lonnie says will ask from D&B at the seminar
Questions about DUNS numbers
What’s the minimum info to give D&B so the registration number could be gotten without this major expense? Is that a way that would work to reduce the workload on both sides as well as the cost? Craig T to follow-up at Webinar on September 9
Question – find vendors DUNS number - finding vendors on our own is less expensive but requires time (extensive time – both calendar and effort)
Is the NDC OK rather than DUNS? FDA response: NDC lets FDA know what establishment is involved – that is acceptable (for right now)
FDA says – Information from Ryan Paul at D&B – about $4 per DUNS if you have account.
Is there an initial $5000 membership fee required? This will be checked
Layout
Order of comments – The comments will be put in a priority order.
4. DIA Webinar tomorrow – 76 signups so far
.
This is the September 8 Webinar. Several members are attending.
5. GPhA F2F – SPL R4 – October 28 in Washington, DC.
Virginia Hogan/Teva will attend representing Generic Sub Team.
6.
DIA F2F – SPL R4 – October 29 & 30 in Philadelphia.
Jeffery Karp/RA-IT Associates will attend representing Generic Sub Team.
7. Waivers for SPL R4 – will be difficult to obtain.
Discussion above
8. Look at whole process for your company.
Different departments being merged to make this process into one group.
Need feedback from other companies to see how this is affecting you.
9. Other/New
Meeting participation is strongly encouraged.
One method suggested is contacting group members regarding issues for future meeting agenda.
Another is a survey/questionnaire to establish the needs of the group.
10. New developments after SPL Generic Sub Team Meeting:
Slides from webinar will be sent out with Meeting Minutes.
It was confirmed by D&B that if just a DUNs number is requested the cost should be $3.55. No membership fee is required.
Our comments were sent to the FDA via GPhA under their letterhead.
10. Meeting attendee list below.
If you attended and are not on the list, please let me know.
11. The next Generic Sub Team meeting is on Monday, September 22
Please send me any agenda items you wish to be discussed.
Call in information:
Toll Free Dial In Number: (866) 618-6746
Int'l Access/Caller Paid Dial In Number: (201) 527-2133
ACCESS CODE: 8957842
Generic Sub Team – Attendees 9/8/08
Name
Company
Brunone, Theresa
Glaxo Smith Kline
Cobham, Michele
Par Pharmaceutical
Desai, Mona
Par Pharmaceuticals
Feliciano, Iris
Sun Pharmaceutical Industries, Inc
Frahn, Jane + 4 team members
Teva Pharmaceuticals
Halleran, Sue
West-ward Pharmaceutical Corp.
Harvey, Mary
Qualitest Pharmaceuticals
Hogan, Virginia
Generic Sub Team Leader
Teva Pharmaceuticals
Karp, Jeffery
Generics Team Minutes
RA-IT Associates
Lempka, Gayle
Watson
Nguyen, Wafa
Qualitest Pharmaceuticals
Peritore, Sal
Barr Laboratories, Inc
Richesson, Cathleen
Ben Venue Laboratories
Saner, Gary - John Lorenc attended for Gary
Reed Technology
Santoro, Amanda
Hospira
Shieh, Betty
Teva Pharmaceuticals
Smith, Lonnie
FDA
Tenaglia, Paul
Apotex, Inc.
Thibodeau, Wendy
Sandoz
Todd, Susan
West-ward Pharmaceutical Corp.
Troutman, Craig
Intagras
Vasquez, Karen
Roxane Laboratories, Inc
Cheng, Evelyn
Teva Global Respiratory Research, LLC